Based on the interpretation of "Information Technology Governance, Risk, and Compliance in Healthcare (Second Edition)," this article is written with special thanks to Professor Wang Anyu for his careful guidance.
Also, thanks to friends Breeder Brother and Steve for their help.
This article is submitted to: https://mp.weixin.qq.com/s/ulk8I5NqN3bU6Gcl3igw2Q
With the rapid development of the healthcare industry, emerging technologies such as cloud computing, artificial intelligence (AI), blockchain, and the Internet of Things (IoT) are driving profound changes in the industry. While these technologies enhance the quality and efficiency of healthcare services, they also bring new challenges in data security, compliance, and risk management. Healthcare organizations (HDOs) must ensure data security and compliance while fully leveraging these technologies, making the establishment and optimization of governance, risk management, and compliance (GRC) frameworks crucial.
To help the healthcare industry deeply understand and effectively respond to these risks, the Cloud Security Alliance Greater China has released the "Information Technology Governance, Risk, and Compliance in Healthcare (Second Edition)" report. The report emphasizes the necessity of designing a robust GRC framework in a cloud computing environment and explores the application of emerging technologies like artificial intelligence in GRC, revealing the opportunities and challenges these technologies bring. Through detailed interpretations of global and local regulations, the report provides compliance strategy recommendations for healthcare organizations, ensuring that organizations maximize the advantages brought by technological innovation while ensuring safety.
The report points out that healthcare organizations (HDOs) are increasingly using cloud services, but the migration to the cloud presents challenges. One major challenge is establishing governance, risk, and compliance (GRC) in the cloud, which requires redefining business and technology processes and relying on third-party providers. To ensure that healthcare organizations can benefit from cloud computing, it is essential to design and implement a robust cloud GRC plan that addresses these challenges and ensures compliance with industry regulations and standards.
Impact of Emerging Technologies on the Healthcare Industry#
The rapid adoption of emerging technologies such as blockchain, IoT, artificial intelligence, and advanced analytics in healthcare presents new challenges and opportunities for GRC frameworks. These technologies can help streamline processes, enhance data integrity, and improve patient outcomes, but they also introduce complexities in compliance and security management. Addressing these technological issues within the GRC framework ensures that they comply with healthcare standards and regulations while enhancing cybersecurity measures.
Cloud computing enables healthcare organizations to efficiently manage and store large amounts of medical data, facilitating seamless sharing and collaboration across regions, thereby improving patient experience. However, cloud computing also raises new data privacy and security management challenges, particularly in multi-tenant environments and shared responsibility models, where data security becomes a top priority.
Artificial Intelligence (AI) brings new vitality to the healthcare industry. From disease prediction to precision medicine, AI systems can process and analyze vast amounts of complex medical data, helping doctors make more accurate decisions. However, the security of AI systems, data quality, and algorithmic ethics have also garnered widespread attention, highlighting the importance of the GRC framework.
IoT technology enhances the quality of patient care by connecting various medical devices and sensors. However, the widespread connectivity of IoT devices also introduces new security vulnerabilities that may directly threaten patient safety.
Governance#
Due to the unique characteristics of cloud computing, which contrast with traditional on-premises data centers, healthcare organizations need to rethink how to achieve IT governance. Healthcare organizations must implement and maintain a governance lifecycle to plan, define, implement, and monitor governance. They must consider how to manage a shared responsibility model and a multi-tenant environment. Furthermore, although a healthcare organization may have a cloud-first strategy, they will initially operate in a hybrid cloud environment. Effective IT governance in healthcare ensures that technology investments align with organizational goals, resources are allocated efficiently, and decision-making processes are transparent and accountable. This includes establishing policies, procedures, and standards for IT systems and personnel.
Cloud-based architectures and business operations are more diverse and complex than traditional on-premises data center architectures, so relying on the same policies and tools used for on-premises data center environments will not ensure success in the cloud. Cloud governance is a collection of strategies and standards for healthcare organizations based on risk and standards frameworks. According to the Information Systems Audit and Control Association (ISACA), governance in cloud environments helps realize the benefits of using cloud computing services while minimizing risks, optimizing investments, and ensuring compliance with legal regulatory requirements.
By creating a cloud governance model, healthcare organizations can avoid many pitfalls of cloud-first strategies. Introducing cloud computing into healthcare organizations will affect roles, responsibilities, processes, and metrics. Without governance to provide standards and guidelines to address risks and effectively procure and operate cloud services, healthcare organizations may find themselves facing common issues such as:
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Misalignment with business objectives
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Frequent policy exception reviews
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Project stagnation
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Compliance or regulatory penalties or failures
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Data governance and management
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Budget overruns
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Incomplete risk assessments
According to the Service-Oriented Architecture (SOA) framework, the cloud governance lifecycle consists of four stages:
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Plan
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Define
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Implement
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Monitor
Risk#
Cloud risk management is the process of identifying, assessing, and controlling risks in modern hybrid cloud environments throughout the lifecycle of cloud relationships. The adoption of different types of clouds (IaaS, PaaS, SaaS) and the lack of visibility into the services and environments provided by CSPs make risk management under the shared responsibility model complex, which is also part of third-party risk management (TPRM). Risk assessments may vary depending on the form of cloud deployment—private cloud, public cloud, or hybrid cloud.
Identifying risks is a foundational activity of risk management; if healthcare organizations fail to identify risks, they will struggle to manage them successfully. Healthcare organizations must ensure they can identify risks promptly and communicate them to the appropriate stakeholders.
Key activities in risk identification include:
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Establishing classifications for risks. A common way to consider threats is to identify the sources of risks/threats. This approach helps categorize risks with common characteristics, tactics, and trends.
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Identifying sources of risks for operational activities that rely on technology and information assets. Reviewing the historical experiences of healthcare organizations regarding negative operational events can be a good first step in identifying sources of risks. Healthcare organizations can start from this list and then customize it based on the scope of their risk management activities and unique operational environments.
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Documenting identified operational risk information in a risk register or other tracking mechanisms. The risk management strategy of healthcare organizations must prioritize operational activities and processes to distinguish those that are already managed from those that are less critical and require lower levels of attention.
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Establishing a reporting mechanism consistent with the way your technology organization is familiar.
Compliance#
Cloud compliance refers to the guidelines, laws, and regulations aimed at protecting and regulating information stored on cloud platforms. For healthcare organizations, this refers to regulations and laws covering security and privacy. This includes how data is stored, protected, and used. Whether it is personally identifiable information (PII), protected health information (PHI), or payment card industry (PCI) data, it must be protected.
Cloud compliance is the process of ensuring that the use of cloud services meets compliance requirements. When healthcare organizations use cloud computing, they do not outsource compliance responsibilities to cloud service providers (CSPs). Regulators and customers can still hold them accountable, as healthcare organizations are responsible for complying with legal regulations, regulatory, and contractual obligations.
Healthcare organizations often rely on third-party vendors and service providers for various IT services. It is crucial to assess the security posture of third-party vendors, conduct due diligence on their security practices, and establish clear contractual agreements outlining security responsibilities and compliance requirements.
Implementing effective cloud compliance policies is essential for organizations to ensure the security and regulatory compliance of their cloud environments. Healthcare organizations should establish clear compliance objectives aligned with industry regulations and their specific business needs. By conducting comprehensive risk assessments, healthcare organizations can identify potential security risks and compliance gaps. Developing clear and documented policies and procedures is crucial. These policies should cover access control, encryption, data processing, incident response and management, change management, vulnerability management, and data breach notification. Continuous monitoring of the cloud environment helps promptly identify and rectify compliance issues or security incidents.
Building Healthcare GRC in the Era of Cloud and AI#
In the rapidly evolving landscape of cloud computing and artificial intelligence (AI), healthcare organizations face unprecedented technological challenges and must reconstruct their governance, risk management, and compliance (GRC) frameworks to meet the complex demands of this emerging technological environment. Cloud computing has introduced highly complex business operation models, requiring healthcare organizations to comprehensively adjust and optimize their existing GRC frameworks.
Data Classification and Management
In a cloud environment, data management becomes more complex as data storage and processing may be distributed across multiple regions and platforms. Healthcare organizations must classify data, clarify data sensitivity levels, and establish corresponding access controls and protection measures. Ensuring the accuracy and consistency of data classification helps reduce the risk of data breaches and comply with relevant regulatory requirements.
Clear Role and Responsibility Allocation
As healthcare organizations address governance and compliance challenges in cloud computing, the application of AI technology further complicates the allocation of responsibilities. With the widespread use of AI large models and generative AI technologies in healthcare, organizations must not only take on responsibilities for data protection and privacy compliance but also ensure the security, data quality, and accuracy of algorithms in AI systems. Healthcare organizations must ensure that every aspect of AI applications, including data input, processing, analysis, and final decision output, complies with security and regulatory requirements, avoiding risks associated with algorithm bias and data privacy breaches.
At the same time, cloud service providers are responsible for aspects such as infrastructure security and data storage compliance, including ensuring the security and stability of the cloud platform and compliance management in multi-tenant environments. The boundaries of responsibility between the two must be clearly defined to ensure effective integration and collaboration of cloud computing and AI systems.
Developing and Implementing Cloud Governance Policies and Standards
Healthcare organizations should establish new governance policies in the cloud computing and AI environment, covering aspects such as the procurement, configuration, access management, and change control of cloud services. Utilizing frameworks like the Cloud Controls Matrix (CCM), healthcare organizations can comprehensively assess and manage security risks arising from the integration of cloud and AI, ensuring compliance and data security.
Continuous Monitoring and Auditing
Due to the constantly changing technological and regulatory requirements, healthcare organizations need to regularly review and update their GRC frameworks to address the latest risks and compliance needs. By implementing Cloud Security Posture Management (CSPM) solutions, healthcare organizations can monitor security configurations in the cloud and AI environment in real time, promptly fixing potential vulnerabilities, thereby enhancing the overall effectiveness of the GRC framework.
Training and Awareness Enhancement
All relevant personnel, including IT teams, management, and business users, need to understand and adhere to the new governance policies and security standards. Through regular training and awareness enhancement, every member should be familiar with their roles and responsibilities within the GRC framework and effectively execute relevant strategies in daily operations.
Building a GRC framework that adapts to the era of cloud and AI requires healthcare organizations to systematically manage multiple aspects, including data management, responsibility allocation, policy formulation, continuous monitoring, and personnel training. Through this comprehensive management, healthcare organizations can enjoy the efficiency and innovation brought by cloud and AI technologies while ensuring data security and compliance.
Furthermore, as the healthcare industry enters the "Digital Intelligence Era," the GRC framework needs to further encompass the application of AI in healthcare data processing and services. By appropriately applying AI technology, healthcare organizations can enhance the precision and accessibility of healthcare services while ensuring effective protection of patient privacy and data security.
Conclusion#
Governance, Risk, and Compliance (GRC) is a set of processes, practices, frameworks, and technologies that help healthcare organizations structure their governance, risk management, and regulatory compliance approaches. Its goal is to unify and coordinate the organization's risk management and regulatory compliance efforts. A well-planned GRC strategy can help healthcare organizations achieve multiple benefits. When adopting cloud computing, healthcare organizations must carefully identify their security needs, assess the security and privacy controls of service providers, and understand the transfer of shared responsibility and compliance obligations. By deeply understanding compliance requirements and conducting comprehensive risk assessments, healthcare organizations can lay the foundation for secure and compliant cloud adaptation. GRC can help align performance activities with business objectives, manage enterprise risks, and meet compliance regulations, ensuring the safety and security of the healthcare service environment.